PSMA and TARP Peptide Vaccine With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment

NCT00694551 | Completed Results

• 3 other identifiers: MCC-1526210634620-14555-05-01
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 2

Brief Summary

Pilot Immunotherapy Study of Combination Prostate Specific Membrane Antigen (PSMA) and T-cell receptor γ alternate reading frame protein (TARP) Peptide With Poly IC-LC Adjuvant in Human Leukocyte Antigens (HLA)-A2 (+) Patients With Elevated prostatic specific antigen (PSA) After Initial Definitive Treatment The purpose of the study is to see if the PSMA/TARP proteins in the vaccine, along with the Hiltonol, can arouse and train the immune system to kill the prostate cancer cells. Prostate cancer is the most common cancer and is the second leading cause of cancer deaths in U.S. males. It is curable when it is confined to the prostate (kept from spreading) using surgery or radiation treatments. In some patients the cancer can come back after these treatments. Treatment options for prostate cancer that comes back include procedures or medications which may have significant risks and side effects. Another plan is being looked at that uses the body's immune system to attack prostate cancer cells. A vaccine has been developed that has proteins found in prostate cancer cells. One of the proteins is called PSMA and the other is called TARP. In addition to these proteins, another substance called Poly IC-LC (Hiltonol) will be added to the vaccine to boost its ability to start the immune system.

Conditions

Prostate Cancer

Keywords

vaccine; PSMA; TARP; immunology; PSA

Outcome Measures

Primary Outcomes (1)

• Occurrence of Related Adverse Events - Grade 3 or Higher

  Number of participants with related Grade 3 or higher adverse events. Establish the safety and toxicity of varying doses of polypeptide vaccines PSMA and TARP administered with a fixed dose of Poly IC-LC as an adjuvant.

  Up to 48 months

Secondary Outcomes (2)

• Number of Participants With Prostatic Specific Antigen (PSA) Doubling

  Up to 48 months

• Number of Participants Who Did Not Have PSA Doubling

  Up to 48 months

Study Arms (3)

A. Level 100 mcg Peptide Vaccine

EXPERIMENTAL

Peptide vaccine dose level 100 mcg + Poly IC-LC

Biological: Peptide Vaccine; Drug: Poly IC-LC

B. Level 300 mcg Peptide Vaccine

EXPERIMENTAL

Peptide vaccine dose level 300 mcg + Poly IC-LC

Biological: Peptide Vaccine; Drug: Poly IC-LC

C. Level 1 mg Peptide Vaccine

EXPERIMENTAL

Peptide vaccine dose level 1 mg + Poly IC-LC

Biological: Peptide Vaccine; Drug: Poly IC-LC

Interventions

Peptide Vaccine BIOLOGICAL

Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.

Also known as: Hiltonol, poly IC-LC, PSMA peptide vaccine, TARP peptide vaccine

A. Level 100 mcg Peptide Vaccine; B. Level 300 mcg Peptide Vaccine; C. Level 1 mg Peptide Vaccine

Poly IC-LC DRUG

Administered subcutaneously, one 2 mg/ml vial,(divided into two equal portions for each injection site).

Also known as: Hiltonol, NSC-301463

A. Level 100 mcg Peptide Vaccine; B. Level 300 mcg Peptide Vaccine; C. Level 1 mg Peptide Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of histologically confirmed prostate cancer.
• Competence to understand the patient information and provide written informed consent, and willingness and ability to return to H. Lee Moffitt Cancer Center for planned treatments and follow-up.
• Absence of evidence of metastatic disease by current physical exam or by current imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\] pelvis, and bone scan within 60 days of first treatment).
• Patients not on hormone therapy (stratum "N") must meet all of these:
• At least 1 year after prostatectomy, definitive prostate radiation, or other definitive-intent local therapy.
• No testosterone suppression therapy for at least 6 months.
• PSA at least 1 ng/ml, on 2 measurements, at least 2 weeks apart.
• Testosterone level \>100 ng/ml, at start ("noncastrate").
• Patients on hormone therapy (stratum "Y") must meet all of these:
• On treatment with gonadotropin-releasing hormone (GnRH) agonist (or orchiectomy) at least 6 months.
• testosterone level \<50 ng/ml, at start.
• PSA at least 1 ng/ml, on 2 measurements, at least 2 weeks apart.
• Laboratory values obtained 0-14 days prior to start of therapy:
• White blood count (WBC) over 3,500/micro L.
• Platelet count over 100,000 micro L.

You may not qualify if:

• Known standard therapy for the patient's disease that is potentially curative.
• A known immunodeficiency including HIV. Appropriate trials for individuals with HIV may be considered at a later date.
• History of other malignancy besides prostate cancer in the last 5 years, except non-melanoma skin cancer treated with local resection only. (The effect of study treatment on other, potentially dormant malignant diseases is not known).
• Use of oral or inhaled or parenteral corticosteroids or of other immunomodulatory drugs within the 60 days of start. \[Use of steroids after start will be considered by the principal investigator (PI) on a case-by-case basis.\]
• Use of estrogens (including herbal phytoestrogens) or ketoconazole within 30 days of start, or during the study.
• Failure to fully recover to grade 1 or better from effects of prior chemotherapy regardless of interval since last treatment.
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational agent in last 30 days (one month washout to start of treatment; patients could register but not start until the washout).
• Known hypersensitivity to one or more components of the study medication.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Ponce School of Medicine

Ponce, 00716, Puerto Rico

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Protein Subunit Vaccines; poly ICLC

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Acellular; Vaccines, Subunit; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Mayer Fishman, M.D., Ph.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

mayer.fishman@moffitt.org

813-745-4398

Study Officials

• Mayer Fishman, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 10, 2008
• Study Start: December 2, 2008
• Primary Completion: February 28, 2013
• Study Completion: December 6, 2018
• Last Updated: October 4, 2019
• Results First Posted: February 19, 2014

Record last verified: 2019-10

Locations

PR (1); US (1)